Development and Validation of a Rp-Hplc Method for the Determination of Chlorpheniramine Maleate and Phenylephrine in Pharmaceutical Dosage Form
Maithani M et al. / Pharmacie Globale (IJCP) 2010, 5 (05)
Available online at www.pharmacie-globale.info
ISSN 0976-8157
Research Article
PHARMACIE GLOBALE
INTERNATIONAL JOURNAL OF COMPREHENSIVE PHARMACY
DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE DETERMINATION
OF CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE IN PHARMACEUTICAL
DOSAGE FORM
Mukesh Maithani*, Richa Raturi, Vertika Gautam, Dharmendra Kumar, Amrendra Kumar Chaudhary,
Anand Gaurav and Ranjit Singh
School of Pharmaceutical Sciences, Shobhit University, NH-58, Modipuram, Meerut, Uttar Pradesh (250 110), India.
Received: 6 November 2010; Revised: 29 November 2010; Accepted: 9 December 2010; Available online: 12 December 2010
ABSTRACT
A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of chlorpheniramine maleate and phenylephrine in tablet dosage forms. A reversed-phase C-18 column (250 mm × 8 mm i.d., particle size 10 µm) column with mobile phase consisting of acetonitrile and phosphate buffer 55:45 (v/v) (pH 5.6 ± 0.02, adjusted with triethylamine) was used. The flow rate was 1.0 ml/ min and effluents were monitored at 255 nm. The retention times of chlorpheniramine maleate and phenylephrine were found to be 3.13 min and 4.58 min, respectively. The method was validated in terms of linearity, range, specificity, accuracy, precision, limit of detection (LOD) and limit of quantitation (LOQ). The linearity for both the drugs was found in the range of 10-70 μg/ml. The % recoveries of chlorpheniramine maleate and phenylephrine were found to be between 101.09 and 98.99. The proposed method was successfully applied to the estimation of chlorpheniramine maleate and phenylephrine in combined tablet dosage forms.
Keywords: Chlorpheniramine maleate, phenylephrine, simultaneous estimation, RP-HPLC, tablet dosage forms.
INTRODUCTION
Chlorpheniramine maleate (CM) chemically,
Available online at www.pharmacie-globale.info
ISSN 0976-8157
Research Article
PHARMACIE GLOBALE
INTERNATIONAL JOURNAL OF COMPREHENSIVE PHARMACY
DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE DETERMINATION
OF CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE IN PHARMACEUTICAL
DOSAGE FORM
Mukesh Maithani*, Richa Raturi, Vertika Gautam, Dharmendra Kumar, Amrendra Kumar Chaudhary,
Anand Gaurav and Ranjit Singh
School of Pharmaceutical Sciences, Shobhit University, NH-58, Modipuram, Meerut, Uttar Pradesh (250 110), India.
Received: 6 November 2010; Revised: 29 November 2010; Accepted: 9 December 2010; Available online: 12 December 2010
ABSTRACT
A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of chlorpheniramine maleate and phenylephrine in tablet dosage forms. A reversed-phase C-18 column (250 mm × 8 mm i.d., particle size 10 µm) column with mobile phase consisting of acetonitrile and phosphate buffer 55:45 (v/v) (pH 5.6 ± 0.02, adjusted with triethylamine) was used. The flow rate was 1.0 ml/ min and effluents were monitored at 255 nm. The retention times of chlorpheniramine maleate and phenylephrine were found to be 3.13 min and 4.58 min, respectively. The method was validated in terms of linearity, range, specificity, accuracy, precision, limit of detection (LOD) and limit of quantitation (LOQ). The linearity for both the drugs was found in the range of 10-70 μg/ml. The % recoveries of chlorpheniramine maleate and phenylephrine were found to be between 101.09 and 98.99. The proposed method was successfully applied to the estimation of chlorpheniramine maleate and phenylephrine in combined tablet dosage forms.
Keywords: Chlorpheniramine maleate, phenylephrine, simultaneous estimation, RP-HPLC, tablet dosage forms.
INTRODUCTION
Chlorpheniramine maleate (CM) chemically,
References: 2. British Pharmacopoeia, The Stationary Office: London, 1998, 1296. 4. Current Index of Medical Specialties, Medimedia Health Private Ltd.: Bangalore, 2006, 253.